Labeling for medical devices is under strict regulations. The requirements are dependent on the class of device, intended use, and market the device is being sold in. Even claims about the device cannot be made on the label without approval. For more information on label claims check out this blog. The FDA outlines the requirements for device labels in Title 21 of the Code of Federal Regulations.[1] Symbols are also used on the label of medical devices to display information about the device. Symbols and their meanings are outlined in ISO 15223-1, which is recommended for use by the FDA. A lot goes into symbols regulation and even though ISO 15223-1 explains what the symbols mean it does not state exactly where the symbols are required to be placed.
To figure out where a symbol should be placed the exact requirements for the type of device should be looked at. For example, a sterile device will have different requirements than a nonsterile device. The levels of packaging also make a difference. Returning to the sterility example, the level of packaging protecting the sterility of the device, the sterile barrier, would need a symbol stating that the device inside is sterile or one stating the sterility of the device is compromised if the packaging is damaged.[2]
The FDA issued a final ruling allowing medical devices to have stand-alone symbols on the label in 2016.[3] This rule allows a symbol to be placed on a label without the need for a written explanation of the meaning of the symbol. The FDA decided upon this rule in an attempt to harmonize with other standards such as ISO 15223 and EU MDR 2017/745.3 Used together with ISO 15223, ISO 7000, and a few other standards this ruling allows for use of symbols in the US that are in line with several other markets around the world, such as the European Union market.
Medical device symbology and determination of symbol placement can be tricky. Attempting to understand all requirements across the various different regulations and standards just adds more to the challenge. EMMA International can help determine what symbols, if any, are needed on a device and where those symbols should be placed. EMMA International provides Full Circle Consulting, give us a call at 248-987-4497 or email info@emmainternational.com to get in touch with our team of experts today.
[1] FDA (October 2020) Device Labeling, Retrieved 12/26/2021 from https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling
[2] Sterile Barrier Association (June 2020) Guidance Document EN ISO 15223-1 new symbols for SBS, Retrieved 12/26/2021 from https://sterilebarrier.org/wp-content/uploads/2020/10/Guidance-Doc-SYMBOLS-201908-1v5.pdf
[3] Federal Register (June 2016) Use of Symbols in Labeling, Retrieved 12/26/2021 from https://www.federalregister.gov/documents/2016/06/15/2016-13989/use-of-symbols-in-labeling
